For ongoing trials the certificates would be issued to only such volunteers who were administered vaccines and not the placebo
The participants will receive the certificates only after the trial has been unblinded
NEW DELHI :
The Union health ministry will provide a data template to Indian Council of Medical Research (ICMR) for compilation of immunization data of participants in covid-19 vaccine clinical trials. The aim is to generate clinical trial volunteers’ vaccination certificates through Co-WIN. Since Covaxin, Covishield and Sputnik V are the only three approved vaccines in India, the government is to issue the certificates only to participants in the trial of these vaccines, the Union health ministry said.
Union health secretary Rajesh Bhushan on Tuesday wrote to ICMR that vaccination certificates shall be issued for only such vaccines which are approved for emergency use in India and to only such volunteers who participated in the trials for such vaccines. “Vaccination certificates can be issued to only such volunteers who were administered vaccines (and not the placebo). Hence, the certificates will be issued to the participants only after the trial has been unblinded," said Bhushan in the letter.
“For the ongoing trials, clear data will have to be maintained by the participating clinical trial sites, about the vaccination status of the volunteers. In such cases, the certificates will be issued to those who were administered the vaccines, only after a clinical trial is unblinded and the vaccine has been approved for emergency use," he said.
The vaccination data for volunteers who participated in the clinical trials was not recorded on Co-WIN as the trials were conducted before the launch of Co-WIN on 16 January 2021. Therefore the physical certificates already provided by the respective hospitals may suffice, government had said earlier.
On 22 July, the health ministry shared the standard operating procedure for issuing physical certificates to such beneficiaries whose vaccination data is not recorded on Co-WIN, along with a copy of the prescribed format in which such physical certificates can be issued, the ministry had said.
Bhushan said in the letter that apart from the fact that vaccination data for the clinical trial volunteers is not available in Co-WIN, factors such as administration of placebo during the trials and that such vaccines that are still under trial are not included in the vaccine masters in Co-WIN, as it has provisions to record vaccination of only approved vaccines, etc., pose additional challenges for issuance of such certificates. In view of the aforesaid factors and challenges, the ministry has decided to adopt a graded approach in the matter.
“The ministry will provide the data template to ICMR for compilation of relevant vaccination data for participants of an unblinded trial, so that necessary details required to issue certificates can be captured on Co-WIN. A utility is being developed in Co-WIN to capture such vaccination data. Data will only be received from the ICMR. ICMR must ensure that only the correct and complete data set is sent to the ministry," said Bhushan.
“Thereafter, certificates will be generated on Co-WIN. Certificates so generated will be accessible to the participants through their account on Co-WIN," he said and added that the data template willshared shortly.